Cleared Traditional

K041659 - C-BOOT

K041659 is an FDA 510(k) clearance for C-BOOT, manufactured by C-Boot , Ltd.. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K041659 · C-Boot , Ltd. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2004
Decision
132d
Days
Class 2
Risk

K041659 is an FDA 510(k) clearance for the C-BOOT. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by C-Boot , Ltd. (Carmiel, IL). The FDA issued a Cleared decision on October 28, 2004 after a review of 132 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5800 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K041659

510(k) Number K041659 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2004
Decision Date October 28, 2004
Days to Decision 132 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 125d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOW Device Classification - Class 2, Special Controls

Product Code JOW Sleeve, Limb, Compressible
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5800
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - JOW Sleeve, Limb, Compressible

All 350
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K041659.
GS-128 GRADIENT COMPRESSION SYSTEM
K050584 · Medmark Technologies, LLC · Mar 2005
MODEL SC-3008 SEQUENTIAL CIRCULATOR
K043423 · Bio Compression Systems, Inc. · Feb 2005
FLOWMEDIC, MODEL 220
K042217 · Flowmedic (Israel), Ltd. · Jan 2005
KENDALL SCD EXPRESS KAMBIA THIGH LENGTH TEARAWAY SLEEVE
K040649 · Tyco Healthcare · Jul 2004
SCD EXPRESS PORTABLE COMPRESSION SYSTEM
K040511 · Tyco Healthcare/Kendall · Jun 2004
JSA'S REPROCESSED COMPRESSION SLEEVE DEVICES
K040065 · Jack Speer and Assoc., Inc. · Mar 2004
K041659 · C-BOOT
Download PDF FDA Summary C-Boot , Ltd.